IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022

Foshan Jindi Electric Appliance Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code OHT· 21 CFR 878.4810

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Product code

OHT
21 CFR 878.4810

Predicate devices

3

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K231717
Device name
IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-06-13
Decision date
2023-09-06
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyLegsBikini / BrazilianUnderarm
Primary application
Body
Classification source
AI classified

Indications for Use

IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Intended Use

IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Device Description

Name of Device: IPL Home Use Hair Removal Device. Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022. Common or Usual Name: Light Based Over-The-Counter Hair Removal. Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Regulatory Class: II. Product Code: OHT. Regulation Number: 21 CFR 878.4810.

Summary parsed at:2026-06-11 04:40:34 UTC

Predicate devices

3

K231717 references 3 predicate/reference devices

Cited as predicate

3

3 submissions cite K231717 as a predicate